N
Patient 1
MDR 3012293198-2018-00016 IS ASSOCIATED WITH ARGUS CASE (B)(4), BIOTENE GEL.
MAUDE MDR 8208792
- MDR report key
- 8208792
- Report number
- 3012293198-2018-00016
- Event key
- 0
- Event type
- 3
- Date received
- 2019-01-02
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 0
- Initial report to FDA
- 0
- Event location
- 3
Manufacturer Contact#
- Address
- PO BOX 13398 RESEARCH TRIANGLE PARK NC 27709 US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | BIOTENE GEL | UNKNOWN | ULTRADENT PRODUCTS INC/ORATECH LLC | LFD | R | * |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-01-02 | 0 | 1. O |
Event Narratives#
D
Patient 1
UNCONSCIOUS. A THICK GEL FORMED AT BACK OF HIS MOUTH (ORAL DISORDER). THICK GEL FORMED AT BACK OF MOUTH MAKING HIM DIFFICULT TO BREATH (DIFFICULTY BREATHING). CASE DESCRIPTION: THIS CASE WAS REPORTED BY A OTHER HEALTH PROFESSIONAL VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF UNCONSCIOUS IN A MALE PATIENT WHO RECEIVED GLYCERIN (BIOTENE GEL) GEL FOR PRODUCT USED FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE GEL. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE GEL, THE PATIENT EXPERIENCED UNCONSCIOUS (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), ORAL DISORDER AND DIFFICULTY BREATHING. THE PATIENT WAS TREATED WITH OXYGEN (OXYGEN THERAPY). THE ACTION TAKEN WITH BIOTENE GEL WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE UNCONSCIOUS, ORAL DISORDER AND DIFFICULTY BREATHING WERE NOT REPORTED. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE UNCONSCIOUS, ORAL DISORDER AND DIFFICULTY BREATHING TO BE RELATED TO BIOTENE GEL. THIS REPORT IS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL DETAILS: THE HEALTH CARE PROFESSIONAL REPORTED THAT THE PATIENT EXPERIENCED THE ADVERSE EVENTS WITH BIOTENE GEL. THE PATIENT USED THE BIOTENE GEL, HE WAS UNCONSCIOUS AND WAS ON OXYGEN. THERE WAS A THICK GEL FORMED AT THE BACK OF HIS MOUTH WHICH MADE HIM VERY DIFFICULT TO BREATH.